Balloon catheter and method for manufacturing it

ABSTRACT

The invention relates to a balloon catheter comprising a catheter tube and an inflatable balloon. The ends of the balloon are attached to the catheter tube. The outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared. The invention also relates to a method for producing such a balloon catheter.

TECHNICAL FIELD

The present invention relates to a balloon catheter comprising a catheter tube and an inflatable balloon which at its ends is attached to the catheter tube. The invention further relates to a method of manufacturing a balloon catheter.

BACKGROUND INFORMATION

Balloon catheters of this type are generally known and are used for dilating vessels and lumina. In order to pass the balloon catheter easily and safely through the vessels and lumina and to position it at the required place for dilatation, it is important that the balloon catheter has a small profile and is sufficiently flexible.

The object of the invention is therefore to provide an improved balloon catheter.

BRIEF SUMMARY OF THE INVENTION

The balloon catheter according to the invention is characterized in that the outside surface of the balloon in an uninflated state is provided with a relief structure which in an inflated state of the balloon is substantially disappeared.

Tests have shown that with a relief structure on the outside surface of the balloon, a catheter is obtained that is more flexible than a standard balloon catheter. The balloon catheter according to the invention can therefore be passed more easily and more safely through vessels and lumina to the point of dilatation. Because of its flexibility, the catheter will be able to adapt better to a bend in a vessel or a lumen, thus reducing the risk of damage to the vessel or lumen.

The required relief structure may have different embodiments, but preferably comprises at least one groove that extends at least transversely in the longitudinal direction of the balloon in order to give the catheter the required flexibility in a direction transverse to the longitudinal direction thereof.

The groove preferably extends at a predetermined angle with respect to the longitudinal direction of the balloon. According to a preferred embodiment the groove extends helically from one end to the other end of the balloon, over the outside surface thereof.

According to another embodiment, the relief structure comprises two or more grooves that extend helically from one end to the other end of the balloon, crossing each other. Tests have shown that with such a relief structure a very flexible balloon catheter is obtained which also has a relatively small profile.

The invention also relates to a method for producing a balloon catheter comprising attaching the ends of an inflatable balloon to a catheter tube, whereby according to the invention the outside surface of the balloon is provided with a relief structure.

According to an embodiment of the invention, the relief structure is produced on the application of heat in order to deform the elastic material of the balloon.

The relief structure is also preferably produced on the surface of the balloon by applying a high pressure to the inside of the balloon.

According to a very inexpensive method, the relief structure is produced on the surface of the balloon by winding a wire around the balloon in the form of a helix.

According to another simple method, the relief structure is produced on the surface of the balloon by taking up the balloon in a counter-pressure body that has the relief structure.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is explained in more detail on the basis of the drawings attached. The drawings show:

FIG. 1A is a side view of a first embodiment of a balloon catheter in an uninflated state,

FIG. 1B is a side view of the catheter in FIG. 1A in an inflated state,

FIG. 2A is a side view of a second embodiment of a balloon catheter in an uninflated state, and

FIG. 2B is a side view of the catheter of FIG. 2A in an inflated state.

DETAILED DESCRIPTION OF THE INVENTION

A balloon catheter according to the invention comprises a catheter tube 1 and an inflatable balloon 2, which at its ends is attached to the catheter tube 1. In an uninflated state (FIGS. 1A and 2A), the outside surface of balloon 2 has a relief structure 4 that in the inflated state has virtually or completely disappeared (FIGS. 1B and 2B). The relief structure gives the catheter its required flexibility.

In the first embodiment according to FIGS. 1A and 1B, the relief structure 4 consists of one groove 5, which extends helically from one end 3 to the other end 3 of the balloon 2, over the outside surface thereof. The uninflated balloon 2 has thereby obtained a helical relief surface. In the second embodiment according to FIGS. 2A and 2B, the relief structure 4 consists of two grooves 5, 6, which extend helically from one end 3 to the other end 3 of the balloon 2 and thereby cross each other. The uninflated balloon 2 has hereby obtained a padded relief surface.

Other relief structures are of course possible, provided that the relief structure on the catheter creates the necessary flexibility in a direction transverse to the longitudinal direction of the balloon.

One way of obtaining the relief structure as shown in the drawings is by winding a wire helically around the balloon 2. If the wire is wound only in the forward direction, the structure according to FIG. 1A is obtained, and if the wire is also wound in the return direction, the structure in FIG. 2A is obtained. After the wire has been wound around the balloon, a sleeve is pulled over the balloon. Subsequently, with the application of raised pressure to the inside of the balloon, the balloon is heated in such a way that, in an uninflated state, the balloon obtains a relief structure that on dilating of the balloon at the dilatation site in the vessel or lumen will virtually or completely disappear. The sleeve is then removed and the balloon catheter can be inserted into a vessel or a lumen.

Instead of winding a wire, the balloon may be placed in a mould, which is provided with the relief pattern required in order for it to obtain, under raised pressure and temperature, the relief structure required.

Before the balloon is provided with its relief structure, preferably it is folded in the usual way in order to reduce its profile. By applying the relief structure, the profile will be reduced still further as an additional, advantageous effect.

Note that, although it is not shown in the drawings, it is possible to provide the outside surface of the balloon with various helical grooves that cross each other. 

1-23. (canceled)
 24. A balloon catheter comprising: a catheter tube disposed on a longitudinal axis; and an inflatable balloon having opposite ends and an outside surface, the ends of the balloon attached to the catheter tube, wherein in an uninflated and folded state, the outside surface that is exposed when the balloon is folded is provided with a groove, which is substantially disappeared when the balloon is in an inflated state at an intended operating pressure during use, and the outside surface that is within a fold of the balloon and not exposed does not have the groove, and wherein the groove fully extends from one end to another end of the opposite ends of the balloon and only over the outside surface that is exposed when the balloon is folded.
 25. The balloon catheter according to claim 24, whereby the groove fully extends at least transversely in a longitudinal direction of the balloon.
 26. The balloon catheter according to claim 25, whereby the groove fully extends at a predetermined angle with regard to the longitudinal direction of the balloon.
 27. The balloon catheter according to claim 25, whereby the groove extends helically from the one end to the another end of the balloon.
 28. The balloon catheter according to claim 27, further including another groove that fully extends helically from the one end to the another end of the balloon and cross each other.
 29. The balloon catheter of claim 24, wherein the balloon includes a first section at one end having a first radial dimension less than a second radial dimension of a second section of the balloon in an inflated state, wherein the groove extends along both the first section and the second section in the uninflated and folded state.
 30. The balloon catheter of claim 24, wherein the balloon includes a frusto-conical portion adjacent each end, and wherein the groove extends at least partially along the frusto-conical portion in the uninflated and folded state.
 31. A catheter, comprising: a catheter shaft disposed on a longitudinal axis; and a balloon mounted on the catheter shaft, the balloon disposed on the shaft and having a continuous balloon wall that is circumferentially folded upon itself about the axis, portions of the folded balloon wall that are exposed to an exterior environment being a first portion of the balloon wall and portions of the folded balloon wall that are not exposed to the exterior environment being a second portion of the balloon wall, a plurality of grooves disposed on the first portion of the balloon wall and not disposed on the second portion of the balloon wall, each of the plurality of grooves disposed to align with an adjacent one of the plurality of grooves and each of the plurality of grooves substantially disappeared when the balloon is in an inflated state at an intended operating pressure during use, wherein the catheter does not include a stent for deployment, and wherein a manufacturing structure which created the plurality of grooves is removed before use.
 32. The catheter of claim 31, the balloon having a plurality of circumferential folds.
 33. The catheter of claim 31, the plurality of aligned grooves are disposed to join together to form a substantially continuous groove extending circumferentially about the axis on the first portion of the balloon wall when the balloon is in an uninflated and folded state.
 34. The catheter of claim 31, the plurality of aligned grooves are disposed to join together to form first and second substantially continuous grooves extending circumferentially about the axis on the first portion of the balloon wall when the balloon is in an uninflated and folded state.
 35. The catheter of claim 34, the first and second substantially continuous grooves intersecting each other.
 36. The balloon of claim 31, wherein the plurality of grooves fully extend from a first end of the balloon to a second, opposite end of the balloon.
 37. A balloon, comprising: a balloon wall defining the balloon and disposed on a longitudinal axis, the balloon wall having first, second, and third portions, the second portion helically disposed between the first and third portions circumferentially about the axis to adjoin the first and third portions, the first portion defining a groove therein having an end terminating where the second portion adjoins the first portion, the third portion defining a groove therein having an end terminating where the second portion adjoins the third portion, the end of the first portion groove proximate to the end of the third portion groove, wherein the grooves of the first, second, and third portions define valleys in the balloon wall separated by peaks in the balloon wall and are substantially disappeared when the balloon is in an inflated state at an intended operating pressure during use, and wherein the valleys remain unoccupied by a stent for deployment when the balloon is in an uninflated and folded state before use in a patient.
 38. The balloon of claim 37, the balloon having a repeating pattern of second portions disposed between first and third portions circumferentially about the axis.
 39. The balloon of claim 37, the grooves of the first and third portions disposed to form a series of aligned grooves extending helically about the axis with a distal end of one of the aligned grooves facing a proximal end of another one of the aligned grooves.
 40. The balloon of claim 39, the series of aligned grooves defining a single helix about the axis.
 41. The balloon of claim 39, the series of aligned grooves defining first and second helixes about the axis.
 42. The balloon of claim 41, the first and second helixes intersecting each other.
 43. The balloon of claim 39, the second portion defining a folded portion of the balloon. 